FineHeart uses hyperMILL^® to make hearts beat faster

FineHeart | Pessac/Bordeaux, France

hyperMILL^® helps with development of an innovative new medical device to treat one of the world’s biggest health problems.

Start-up company FineHeart is developing an innovative medical device that aims to address one of the world’s biggest health problems with the help of OPEN MIND Technologies' hyperMILL^® CAM solution. The aim is to provide support for the hearts of patients who suffer from severe heart failure and are currently not being treated by therapies available on the market.

This degenerative disease is the second most common cause of death in G8 countries after cancer, with 200,000 new cases every year. To bring this cutting-edge technology called ICOMS (Implantable Cardiac Output Management System) to life and to produce the prototypes required for the tests, FineHeart chose hyperMILL^® in 2016. What made the difference? The 5-axis simultaneous turbine machining strategy, collision detection, surface quality and ease of use.

FineHeart was founded in 2010 in Pessac, in the Bordeaux area of France through a coming-together of surgical cardiologists, engineers and managers from the biomedical industry. The company's business is focused on the creation of innovative technologies in the cardiovascular field. Arnaud Mascarell, CEO and co-founder, started his career as an R&D engineer at Air Liquide in 1997 and then joined Medtronic - a major player in the biomedical industry. After 17 years in the clinical environment, Arnaud Mascarell completed his education with an MBA from IAE Paris and a degree from HEC start-up. His taste for entrepreneurship led him to co-found FineHeart with Dr Stephane Garrigue, the inventor of the concept that could only be completed to the standards required with the application of hyperMILL^®.

“hyperMILL® is a very powerful tool. The collision detection feature made all the difference. The surfaces to be machined are not very accessible. The parts and tools are small. It's about micro-mechanics.”

Julien Cardon, CAM programmer

Why is a new medical device to treat heart failure necessary?

Current devices do not provide the best results and many patients are left without a solution. Heart transplantation is reserved for the most severe patients - one to two hospitalizations per month - and whose age does not exceed 60 years, i.e. 3% of the entire population suffering from heart failure. On the other hand, there are fewer and fewer donors, partly due to the decrease in road fatalities. Out of 200,000 new cases of severe kidney failure per year worldwide, 50,000 are considered for transplantation but only 5,000 of them get one.

To address this major health issue, FineHeart created a new medical device using cutting-edge technology that would be suitable for a maximum number of patients. It is a question of treating the problem upstream and even treating the patients themselves.

Innovation with minimally invasive ICOMS

ICOMS is the result of the collaboration and expertise of two renowned doctors in cardiac surgery/cardiology and two management experts in the medical device industry. It is an intracardiac mini-pump, fully implantable and wireless. The pump and battery (5h autonomy, rechargeable with an abdominal belt) are embedded in the patient's body and the system respects the physiology of the heart and enables it to normalize. It will considerably improve the quality of life for patients, giving them the capacity to ride a bicycle again, take a shower or go for a walk without any limitations.

Unlike other cardiac assist devices on the market, ICOMS does not require extensive open-chest surgery to implement. About the size of an index finger and weighing no more than 85g, the mini-turbine is implanted by a minimally invasive surgical procedure, well known to surgeons.

The ICOMS device, a mini intracardiac pump, is fully implantable and wireless.

Since 2010, several major technological milestones have been achieved by FineHeart such as the finalization of the pump design and performance, the creation of pump prototypes, the development of the overall system and the first animal experiments and in-vitro tests. In 2016, once the product design stage had been validated, the start-up recruited. It now employs 35 people and has invested in two 5-axis machining centers and CAM software to program the machining strategies.

hyperMILL^® CAM makes the difference for prototype machining

Arnaud Mascarell comments: “ICOMS is a very sophisticated pump with a special design. We needed CAM software that could machine extremely complex-shaped parts, including the turbine in 5 continuous axes. We also needed to generate a flawless surface quality without any risk of snagging on red blood cells.”

Two CAM software developers were invited for benchmark tests. hyperMILL^® has made a name for itself with its 5-axis continuous machining performance, specifically with its ‘turbine machining’ strategy, which is perfectly suited to the part and very easy to use. The device is a 150mm tube, 18mm in diameter, which incorporates internal parts of complex shapes with small fillets and radii, for example, cylindrical shapes with blades. Tests were carried out on the machine at the DMG MORI facility. The prototypes were manufactured, and the tests proved to be very conclusive. Julien Cardon, an experienced CAM programmer, adds: “hyperMILL^® is a very powerful tool. The collision detection feature made all the difference. The surfaces to be machined are not very accessible. The parts and tools are small. It's about micro-mechanics.”

From left to right: Julien Cardon, CAM programmer and Arnaud Mascarell, CEO, and co-founder of FineHeart.

hyperMILL^® was the software of choice and Julien Cardon was trained on the CAM system, saying: “I found it extremely interesting and convenient to use hyperMILL^® directly on the parts I had to make. I was up and running very quickly, after about two weeks." The device includes about fifteen items to be machined, exclusively in titanium. It is pure turning for some parts or milling in 5 continuous axes for others. “As for the surface quality obtained , it is impressive, almost poly-mirror. We obtain a Ra <0.3 microns at the end of machining. We even perform a polish to get 0.2 microns," he specifies

A powerful tool and a team that listens and is available

After a few years of use, Julien Cardon says he appreciates the interface, which he describes as very user-friendly and the ease of use of the software. He adds: “The speed of execution, the reliability and the post-processors generated by OPEN MIND, which is perfectly suited to the machine's kinematics is a huge advantage.” The programmer is extremely impressed with the level of service, support and responsiveness of the OPEN MIND team.

What's the next step?

FineHeart now aims to evolve and finalize its product to schedule the first human clinical trials in 2022. In addition to saving lives, FineHeart estimates savings of over €2 billion for the 4 years following ICOMS implementation, thanks to the reduction in mortality and the number of hospitalizations. The number of people with heart disease is growing rapidly. The annual cost of caring for people with heart failure is US$30 billion. With 20,000 new cases per year in France, the annual cost represents €975 million, 85% of which is due to long and repeated hospitalizations.

www.fineheart.fr